Regulation

UK animal research regulation

There have been special controls on the use of laboratory animals in the UK since 1876. These were revised and extended in 1986 as the Animals (Scientific Procedures) Act (ASPA). ASPA has recently been revised to transpose European Directive 2010/63/EU on the protection of animals used for scientific purposes.

The revised legislation came into force on 1 January 2013. This law safeguards laboratory animal welfare while allowing important medical research to continue. These controls are widely regarded as the strictest in the world.

Central to the Animals (Scientific Procedures) Act 1986 is a cost-benefit assessment which must be applied before any research project involving animals can go ahead. Thus the costs, in terms of potential animal suffering, must be weighed against the potential benefits of the research. Draft guidance on the operation of ASPA was published on 29 January 2013.

The draft guidance explains what amended ASPA requires and provides detailed guidance to holders of establishment licences, project licences and personal licences and new licence applicants. It also provides guidance on severity classification and humane killing.

Licences

Three separate types of licence are required for animal research or testing. The Act says that animal procedures can only:

take place in research institutes or companies which have appropriate animal accommodation and veterinary facilities, and have been granted a certificate of designation

be part of an approved research or testing programme which has been given a project licence

be carried out by people with sufficient training, skills and experience as shown in their personal licence

Licences are only granted if:

the potential results are important enough to justify the use of animals (the cost benefit analysis)

the research cannot be done using non-animal methods

the minimum number of animals will be used

dogs, cats or primates are only used when other species are not suitable

any discomfort or suffering is kept to a minimum by appropriate use of anaesthetics or pain killer

researchers and technicians conducting procedures have the necessary training, skills and experience

research premises have the necessary facilities to look after the animals properly (as laid down in a Home Office Code of Practice).

Additional controls

In addition, a whole new level of regulation took effect in April 1999, with the introduction of local ethical review. In most countries, the regulation of animal research operates either through local ethical committees or by statutory controls imposed by central government. The UK is the only country in the world to have both systems operating at the same time.

This is just one of many extra policies and codes that have been added to the regulation of animal research in the UK since 1986.

There is now widespread recognition that the UK controls are too complex and bureaucratic and the Home Office is working towards better regulation of animal research.

Other relevant regulations

Safety testing is usually carried out so that medicines and other products* meet particular UK, foreign or international regulations. In 2010, about 10% of scientific procedures were conducted to comply with the provisions of such regulations. Relevant UK laws and regulations include:

Medicines Act 1968

Health and Safety at Work Act 1974

Control of Substances Hazardous to Health 1988

Control of Pesticides Regulations 1986

Food and Environment Protection Act 1985

Food Safety Act 1990

Consumer Protection Act 1987

New products often have to undergo a range of different tests to meet the requirements of regulatory authorities in different countries. Efforts are being made to harmonise requirements, which should lead to further reductions in laboratory animal use.